Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Cedars-Sinai Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Parke-Davis
Information provided by (Responsible Party):
Noel Bairey Merz, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00600106
First received: January 11, 2008
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

For the purposes of this study, as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript.


Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: WISE Ancillary Study Data Analyses:Efficacy of Hormone Replacement on Myocardial Ischemia in Postmenopausal Women With Normal/Minimal Coronary Artery Disease: Data Analysis

Resource links provided by NLM:


Further study details as provided by Cedars-Sinai Medical Center:

Estimated Enrollment: 48
Study Start Date: April 2006
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Numerous unexpected events occurred during the course of this study led to incomplete and underpowered results.

Recruitment was closed prematurely due to failure to recruit following publication of the Women's Health Initiative hormone trial. No conclusions could be drawn due to the power limitation.

We lost the P31 MR Spectroscopy core lab when WISE MR expert investigators moved to new institutions from the WISE MR CORE site (at UAB from 1996 to 2001). The planned P31tests could not be completed with the same protocols used for the initial phase of the WISE.

Initial WISE cohort brachial artery FMD data showed large variability and FMD was only weakly associated with presence of CAD (Am Heart J 2002; 802-807). Also in WISE women FMD failed to correlate with directly measured coronary artery endothelial dysfunction in response to intracoronary acetylcholine. So enthusiasm for FMD testing waned among the WISE investigators. No conclusions could be drawn due to the power limitations.

We observed that only about 50% of WISE women in the initial cohort could perform the modified ACIP protocol (used in this substudy for ETT) and even when we excluded nondiagnostic studies the respective sensitivities and specificities were only 43 and 66% (Am Heart J 2005;149;527-533). So only 16 and 17 women from the placebo and FemHRT groups, respectively, completed ETTs at 16 weeks among the 37 randomized and the majority of these were "indeterminate". Exercise duration, was specified as a secondary outcome measure. No conclusions could be drawn due to the power limitations.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

postmenopausal women

Criteria

Inclusion Criteria:

  • Previously collected samples gathered from the WISE Anc. FemHrt study.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00600106

Locations
United States, California
Cedars-Sinai Women's Heart Center, 444 S. San Vicente Blvd, Suite 600 &901
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Parke-Davis
Investigators
Principal Investigator: C. Noel Bairey Merz, MD Cedars-Sinai Medical Center
  More Information

No publications provided by Cedars-Sinai Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Noel Bairey Merz, Director, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00600106     History of Changes
Other Study ID Numbers: 9260, 9260
Study First Received: January 11, 2008
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 18, 2014